Cleared Traditional

ARTHREX TOURNIQUET FOR LEG HOLDER (K933994) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K933994 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
218d
Days
Class 1
Risk

K933994 is an FDA 510(k) clearance for the ARTHREX TOURNIQUET FOR LEG HOLDER. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 218 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K933994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date March 23, 1994
Days to Decision 218 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 115d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KCY Tourniquet, Pneumatic

All 33
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K933994.
ATS 5000 Automatic Tourniquet Instrument
K202919 · Mcewen and Associates Consulting , Ltd. · May 2021
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · Zimmer, Inc. · Aug 2013
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc. · Sep 2005
TEST PRESSURE GAUGE #6675-32
K791759 · Depuy, Inc. · Oct 1979